Trial Outcomes & Findings for Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures (NCT NCT00448916)
NCT ID: NCT00448916
Last Updated: 2021-01-25
Results Overview
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
54 participants
Primary outcome timeframe
12 Months
Results posted on
2021-01-25
Participant Flow
This study was a dose extension study of pediatric participants with refractory partial-onset seizures who had completed study A0081074 (NCT00437281). Participants were enrolled in 3 countries at 13 study centers with 13 investigators: Republic of Korea (1 center), Mexico (1 center), and the United States (11 centers).
Each participant was restricted to the dose levels that they had previously tolerated, or that had shown acceptable safety and tolerability in study A0081074 (NCT00437281) for the participant's age group.
Participant milestones
| Measure |
Pregabalin: 1-23 Months
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
16
|
15
|
12
|
11
|
|
Overall Study
COMPLETED
|
9
|
9
|
6
|
5
|
|
Overall Study
NOT COMPLETED
|
7
|
6
|
6
|
6
|
Reasons for withdrawal
| Measure |
Pregabalin: 1-23 Months
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
2
|
2
|
3
|
2
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Open-Label Extension Study Of Safety And Tolerability Of Pregabalin In Pediatric Patients With Partial-Onset Seizures
Baseline characteristics by cohort
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
1.18 Years
STANDARD_DEVIATION 0.57 • n=5 Participants
|
4.14 Years
STANDARD_DEVIATION 1.23 • n=7 Participants
|
9.98 Years
STANDARD_DEVIATION 1.30 • n=5 Participants
|
14.86 Years
STANDARD_DEVIATION 1.53 • n=4 Participants
|
6.74 Years
STANDARD_DEVIATION 5.35 • n=21 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
25 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
An AE is any untoward medical occurrence in a clinical investigation participant administered a product or medical device; the event need not necessarily have a causal relationship with the treatment or usage. A serious adverse event (SAE) is any untoward medical occurrence at any dose that: results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AE).
Participants with AEs
|
14 Participants
|
13 Participants
|
11 Participants
|
9 Participants
|
|
Number of Participants With Adverse Events (AE).
Participants with serious AEs
|
8 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events (AE).
Participants with severe AEs
|
7 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.Population: Safety analysis set: All participants who received at least one dose of study medication were included.
Changes from previous examinations in physical examination were reported. Examination of abdomen, breasts, ears, extremities, eyes, genitourinary, head, heart, lungs, lymph nodes, mouth, musculoskeletal, neck, nose, ocular fundi, skin, throat, thyroid and general examinations were done. Evaluation was done based on presence of abnormality which were noted as "abnormal" and no abnormalities in the sites were reported as "normal". Any change from the previous physical examination results were noted.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Week 1 (N=16,13,11,10)
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Month 1 (N=14,13,10,10)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Month 6 (N=11,10,6,7)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Month 12/Eary Termination (N=16,12,12,9)
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Change From Previous Physical Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Follow-up (N=6,4,9,6)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-upPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Changes from previous examinations in neurological examination were reported. The neurologic exam were performed by a pediatric neurologist or qualified staff member. Coordination, cranial nerves, gait, level of consciousness, lower and upper extremity sensation, muscle strength, muscle tone, nystagmus, reflexes, Romberg test, and speech were examined.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Week 1 (N=16,13,11,10)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Month 1 (N=14,13,10,10)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Month 6 (N=11,10,6,7)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Month 12/Early Termination (N=16,11,12,9)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Change From Previous Neurological Examination Results at Visit 1, Week 1, Month 1, Month 6, Month 12/Early Termination and Follow-up.
Follow-up (N=6,4,9,6)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 1 to 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Participants with significant supine diastolic BP values with the criteria ≥ 20% increase from Baseline or ≥ 20% decrease from Baseline or \> 1.25 times upper limit of normal (ULN) or \< 0.9 times lower limit of normal (LLN) were identified and recorded. The categorical summary of Post-Baseline supine diastolic BP data are presented below.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).
≥ 20% increase from Baseline
|
12 Participants
|
5 Participants
|
8 Participants
|
3 Participants
|
|
Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).
≥ 20% decrease from Baseline
|
5 Participants
|
7 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).
> 1.25 * ULN
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Change in Supine Diastolic Blood Pressure (BP) at Post-Baseline Visits (Visit 1 to 12 Months).
< 0.9 * LLN
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 1 to 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Participants with significant supine systolic BP values with the criteria ≥ 30% increase from Baseline or ≥ 30% decrease from Baseline or \> 1.25 times ULN or \< 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine systolic BP data are presented below.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).
≥ 30% increase from Baseline
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).
≥ 30% decrease from Baseline
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).
> 1.25 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Change in Supine Systolic BP at Post Baseline Visits (Visit 1 to 12 Months).
< 0.9 * LLN
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Visit 1 to 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Participants with significant heart rate values with the criteria \> 1.5 times ULN or \< 0.9 times LLN were identified and recorded. The categorical summary of Post-Baseline supine HR data are presented below.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).
> 1.5 * ULN
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Significant Change in Supine Heart Rate (HR) at Post Baseline Visits (Visit 1 to 12 Months).
< 0.9 * LLN
|
5 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 12/Early TerminationPopulation: Safety analysis set: All participants who received at least one dose of study medication were included. Data was available for 15, 11, 10 and 7 participants in Pregabalin 1-23 months group, 2-6 years group, 7-11 years group and 12-16 years group respectively.
BMI was calculated from height and weight measured at Month 12 visit using the formula: weight(kg)/height(m)2.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=15 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=11 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=10 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=7 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Derived Body Mass Index Data (BMI) at Month 12/Early Termination.
|
16.2 Kg/m^2
Standard Deviation 1.73
|
18.0 Kg/m^2
Standard Deviation 3.52
|
20.6 Kg/m^2
Standard Deviation 6.52
|
24.8 Kg/m^2
Standard Deviation 7.72
|
SECONDARY outcome
Timeframe: Baseline, Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-upPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Weight was recorded in kilograms and weight change from Baseline was reported.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Month 4 (N=11,10,7,9)
|
1.3 Kg
Standard Deviation 0.86
|
1.3 Kg
Standard Deviation 1.29
|
5.2 Kg
Standard Deviation 4.32
|
4.1 Kg
Standard Deviation 2.28
|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Day 9 (N=16,14,12,11)
|
0.1 Kg
Standard Deviation 0.16
|
0.1 Kg
Standard Deviation 0.29
|
-0.1 Kg
Standard Deviation 0.79
|
0.4 Kg
Standard Deviation 1.07
|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Week 1 (N=16,13,11,10)
|
0.3 Kg
Standard Deviation 0.29
|
0.4 Kg
Standard Deviation 0.61
|
1.5 Kg
Standard Deviation 1.15
|
1.2 Kg
Standard Deviation 1.43
|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Month 1 (N=14,13,10,10)
|
0.4 Kg
Standard Deviation 0.45
|
0.8 Kg
Standard Deviation 0.73
|
2.1 Kg
Standard Deviation 1.77
|
2.4 Kg
Standard Deviation 1.52
|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Month 2 (N=11,12,8,9)
|
1.0 Kg
Standard Deviation 0.73
|
1.2 Kg
Standard Deviation 1.12
|
3.8 Kg
Standard Deviation 3.25
|
3.0 Kg
Standard Deviation 1.81
|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Month 6 (N=11,10,6,7)
|
1.8 Kg
Standard Deviation 0.98
|
1.4 Kg
Standard Deviation 1.52
|
5.9 Kg
Standard Deviation 4.17
|
5.9 Kg
Standard Deviation 3.32
|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Month 9 (N=9,10,6,5)
|
2.4 Kg
Standard Deviation 1.18
|
2.3 Kg
Standard Deviation 2.52
|
6.3 Kg
Standard Deviation 4.66
|
7.3 Kg
Standard Deviation 4.32
|
|
Change From Baseline in Body Weight at Day 9, Week 1, Month 1, Month 2, Month 4, Month 6, Month 9, Month 12/Early Termination and Follow-up.
Month 12/Early Termination (N=15,12,11,8)
|
1.8 Kg
Standard Deviation 1.33
|
2.4 Kg
Standard Deviation 2.71
|
6.0 Kg
Standard Deviation 4.78
|
6.6 Kg
Standard Deviation 4.51
|
SECONDARY outcome
Timeframe: Month 12/Early TerminationPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Height was recorded in centimeters.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=15 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=11 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=10 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=7 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Height at Month 12/Early Termination.
|
83.3 cm
Standard Deviation 8.87
|
109.9 cm
Standard Deviation 12.76
|
145.6 cm
Standard Deviation 13.21
|
167.3 cm
Standard Deviation 8.18
|
SECONDARY outcome
Timeframe: Week 1 to 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Based on the criteria for safety values of potential clinical concern, the PR interval (≥200 msec; ≥25% increase from Baseline; ≥50% increase from Baseline), QRS complex (≥200 msec; ≥25% increase from Baseline), QT (≥500 msec), maximum QTcB interval (450-\<480; 480-\<500; ≥500 msec) and maximum QTcF interval (450-\<480; 480-\<500; ≥500 msec) values were calculated. Baseline was defined as Day 1 of the parent study A0081074 (NCT00437281). Categorical data of the Post-Baseline vists are represented below.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QTcF interval: ≥ 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QTcB interval: ≥ 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QTcF interval: 450-<480 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QTcF interval: 480-<500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
PR interval: ≥ 200 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
PR interval: ≥50% increase from Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
PR interval: ≥25% increase from Baseline
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QRS interval: ≥ 200 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QRS interval: ≥25% increase from Baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QT interval: ≥ 500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QTcB interval: 450-<480 msec
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Changes in Electrocardiogram (ECG) Data Post-Baseline Visits (Week 1 to 12 Months).
QTcB interval: 480-<500 msec
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the values are: platelets (10\*3/mm\*3): \<0.5 LLN or \>1.75 ULN; white blood cell (WBC) count (X10E9/L): \<0.6 LLN or \>1.5 ULN; lymphocytes-Abs (10\*3/mm\*3): \<0.8 LLN or \>1.2 ULN; total neutrophils-Abs (10\*3/mm\*3): \<0.8 LLN or \>1.2 ULN; and eosinophils-Abs: \>1.2 ULN.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Hematotolgical Abnormalities.
Platelets: <0.5xLLN (N=16,15,12,11)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Platelets: >1.75xULN (N=16,15,12,11)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
WBC count: <0.6xLLN (N=15,15,12,11)
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
WBC count: >1.5xULN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Lymphocytes-Abs: <0.8xLLN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Lymphocytes-Abs: >1.2xULN (N=15,15,12,11)
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Total neutrophils-Abs: <0.8xLLN (N=15,15,12,11)
|
3 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Total neutrophils-Abs: >1.2xULN (N=15,15,12,11)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Eosinophils-Abs: >1.2xULN (N=15,15,12,11)
|
3 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Red blood cell count: <0.8xLLN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Hemoglobin: <0.8xLLN(N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Hematocrit: <0.8xLLN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Basophils: >1.2xULN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Hematotolgical Abnormalities.
Monocytes: >1.2xULN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Participants with Urine Protein (mg/dL) abnormalities (≥1) were noted based on urinalysis (dipstick). No participants with abnormalities in urinalysis (microscopy) were noted.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=11 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=11 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Urinalysis (Dipstick/Microscopy).
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Based on criteria for safety values of potential clinical concern, the participants with abnormal values were noted. Some of the criteria are: Free thyroxine (T4 free) (ng/dL): \<0.8 LLN or \>1.2 ULN and Thyroid-stimulating hormone (TSH) (mu/L): \<0.8 LLN or \>1.2 ULN.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Endocrine Panel (Hormones).
T4 (free): <0.8xLLN (N=13,13,11,10)
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Endocrine Panel (Hormones).
T4 (free): >1.2xULN (N=13,13,11,10)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Endocrine Panel (Hormones).
TSH: <0.8xLLN (N=14,12,11,10)
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Endocrine Panel (Hormones).
TSH: >1.2xULN (N=14,12,11,10)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Based on criteria for safety values of potential clinical concern, the participants with abnormal values in creatine kinase (\>2.0 times upper limit of the reference range) (u/L) were noted.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=15 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Creatine Kinase.
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 28 DaysPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Twenty-eight-day seizure frequencies were to be calculated from the seizure diaries and were to be reviewed. However, due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed. Hence, the seizure data was reported as AE.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=16 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Seizure Frequency.
|
NA Participants
Due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed
|
NA Participants
Due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed
|
NA Participants
Due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed
|
NA Participants
Due to the nature of the data collection and due to unability to clearly differentiate no seizures versus seizures, accurate computation of this data was not performed
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Safety analysis set: All participants who received at least one dose of study medication were included.
Based on criteria for safety values of potential clinical concern, the participants with abnormal values in liver function tests, renal function tests, lipid profile, electrolytes, glucose, Insulin like growth factor (IGF) and IGF binding protein were noted and reported in this section.
Outcome measures
| Measure |
Pregabalin: 1-23 Months
n=15 Participants
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 Participants
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 Participants
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 Participants
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
|---|---|---|---|---|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Magnesium: >1.1xULN (N=15,15,12,11)
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Alanine Aminotransferase: >3.0xULN (N=15,15,12,11)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Blood Urea Nitrogen: >1.3xULN
|
2 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Albumin: <0.8xLLN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Albumin: >1.2xULN (N=15,15,12,11)
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Potassium: <0.9xLLN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Potassium: >1.1xULN (N=15,15,12,11)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Magnesium: <0.9xLLN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Phosphate: <0.8xLLN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Phosphate: >1.2xULN (N=15,15,12,11)
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Bicarbonate (venous): <0.9xLLN (N=15,15,12,11)
|
9 Participants
|
11 Participants
|
7 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Bicarbonate (venous): >1.1xULN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Glucose: <0.6xLLN (N=15,15,12,11)
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Glucose: >1.5xULN (N=15,15,12,11)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Insulin-like GrowthFactor:<0.9xLLN(N=12,13,11,10)
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Insulin-like GrowthFactor:>1.1xULN(N=12,13,11,10)
|
5 Participants
|
8 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
IGF Binding Protein: <0.9xLLN (N=12,13,11,10)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
IGF Binding Protein: >1.1xULN (N=12,13,11,10)
|
4 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Chemistry (Including Liver Function, Renal Function, Lipids, Electrolytes, Glucose, Insulin Like Growth Factor (IGF) and IGF Binding Protein).
Lipid profile cholesterol/triglycerides(N=1,4,0,1)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Pregabalin: 1-23 Months
Serious events: 8 serious events
Other events: 14 other events
Deaths: 0 deaths
Pregabalin: 2-6 Years
Serious events: 3 serious events
Other events: 13 other events
Deaths: 0 deaths
Pregabalin: 7-11 Years
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Pregabalin: 12-16 Years
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
Overall
Serious events: 12 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pregabalin: 1-23 Months
n=16 participants at risk
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 participants at risk
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 participants at risk
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 participants at risk
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Overall
n=54 participants at risk
This arm summarizes the AE data from all the treatment groups.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Ileus
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Croup infectious
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis media acute
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Status epilepticus
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Unresponsive to stimuli
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial hyperreactivity
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Other adverse events
| Measure |
Pregabalin: 1-23 Months
n=16 participants at risk
Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
|
Pregabalin: 2-6 Years
n=15 participants at risk
Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
|
Pregabalin: 7-11 Years
n=12 participants at risk
Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Pregabalin: 12-16 Years
n=11 participants at risk
Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
|
Overall
n=54 participants at risk
This arm summarizes the AE data from all the treatment groups.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytosis
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Cardiac disorders
Bundle branch block left
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Congenital, familial and genetic disorders
Cryptorchism
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Cyclic neutropenia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Blood and lymphatic system disorders
Normochromic normocytic anaemia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Astigmatism
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Conjunctivitis
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Excessive eye blinking
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Eye disorders
Hypermetropia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal pain
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
31.2%
5/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.0%
7/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
3/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
6/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Faeces pale
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.4%
4/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Crying
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Fatigue
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Irritability
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Pyrexia
|
56.2%
9/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
3/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
27.3%
3/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
27.8%
15/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
General disorders
Thirst
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bacterial sepsis
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Cystitis
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Device related infection
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Ear infection
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
26.7%
4/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.3%
5/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Eye infection
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Gastroenteritis
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Hordeolum
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis media
|
25.0%
4/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
26.7%
4/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
14.8%
8/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Otitis media acute
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
2/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pharyngotonsillitis
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Pneumonia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Rhinitis
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
33.3%
5/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
16.7%
2/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
18.5%
10/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Anal injury
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
18.2%
2/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Anticonvulsant drug level increased
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Investigations
Weight increased
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Convulsion
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
25.0%
3/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.0%
7/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Headache
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
2/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Partial seizures
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Somnolence
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.4%
4/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Nervous system disorders
Status epilepticus
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Anger
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Dissociation
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Dysphemia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Dyssomnia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Hallucination, visual
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Insomnia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
3.7%
2/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Psychiatric disorders
Restlessness
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Renal and urinary disorders
Urine odour abnormal
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
4/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
2/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
6/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
2/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
9.1%
1/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.4%
4/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
20.0%
3/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
11.1%
6/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
2/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
13.3%
2/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
5.6%
3/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Snoring
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
18.8%
3/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
7.4%
4/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
8.3%
1/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
6.7%
1/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
|
Surgical and medical procedures
Adenoidectomy
|
6.2%
1/16 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/15 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/12 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
0.00%
0/11 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
1.9%
1/54 • From Visit 1 to Visit 9 (Follow-up visit)
The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER